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Monoclonal Antibodies

Cohort A: Immunotherapy Naive for Cervical Cancer

Phase 2

Recruiting

Led By Meghan Shea, MD

Research Sponsored by Meghan Shea

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age of 18 or greater years

Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

Study Summary

This trial is testing how well a combination of dostarlimab and cobolimab works in treating advanced cervical cancer that has spread or come back.

Who is the study for?

This trial is for adults with measurable, recurrent or metastatic cervical cancer. They must have good organ function and performance status, no severe prior treatment side effects, and not be pregnant or breastfeeding. Those previously treated for hepatitis C can join if cured. Exclusions include past immune checkpoint inhibitor therapy, recent chemo or radiotherapy, active autoimmune diseases, HIV/AIDS, current serious illnesses, use of immunosuppressants or live vaccines recently.Check my eligibility

What is being tested?

The study tests the effectiveness of combining two drugs: Dostarlimab and Cobolimab in treating advanced cervical cancer that has spread (metastatic) or returned after treatment (recurrent). The goal is to see how well these drugs work together against this type of cancer.See study design

What are the potential side effects?

Potential side effects may include allergic reactions similar to those from compounds related to Dostarlimab and Cobolimab. There's also a risk of worsening autoimmune disease symptoms due to the immune-stimulating nature of the treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I had hepatitis C but have been treated and cured.

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Side effects from my previous treatments are mild or gone.

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My cervical cancer diagnosis was confirmed through lab tests.

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I can take care of myself and perform daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Objective Response Rate (ORR) Based on irRECIST

Secondary outcome measures

Grade 3-5 Adverse Events Rate

Immune-Related (PFS) Progression-Free Survival

Median Overall Survival (OS)

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort B: Immunotherapy ExposedExperimental Treatment2 Interventions

14 Participants will complete study procedures as follows: Baseline visit. Imaging tests at baseline visit, at week 9, and then every 12 weeks. Cycle 1 through End of Treatment (up to 2 years of treatment): • Day of 21 Day cycle: Predetermined dose of Dostarlimab 1x daily. Predetermined dose of Cobolimab 1x daily. End of Treatment visit with blood tests and imaging tests. Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If >= 2 participants with objective responses, then 23 additional participants will be enrolled.

Group II: Cohort A: Immunotherapy NaiveExperimental Treatment2 Interventions

10 Participants will complete study procedures as follows: Baseline visit. Imaging tests at baseline visit, at week 9, and then every 12 weeks. Cycle 1 through End of Treatment (up to 2 years of treatment): • Day 1 of 21 Day cycle: Dostarlimab 1x daily and Cobolimab 1x daily. End of Treatment visit with blood tests and imaging tests. Follow Up Period: Every 3 months for 2 years and then every 6 months for an additional 5 years. Includes imaging tests. If >= 2 participants with objective responses, then 19 additional participants will be enrolled.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cobolimab

2016

Completed Phase 1

~830

Dostarlimab

2020

Completed Phase 2

~1000

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Meghan SheaLead Sponsor

GlaxoSmithKlineIndustry Sponsor

4,755 Previous Clinical Trials

8,070,750 Total Patients Enrolled

Meghan Shea, MDPrincipal InvestigatorBeth Israel Deaconess Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the recruitment phase of this clinical trial still ongoing?

"According to the details on clinicaltrials.gov, this particular medical trial is not currently seeking new participants. It was first listed on July 1st, 2024 and the most recent update was made on January 25th, 2024. Despite this specific trial being inactive in terms of recruitment, there are a substantial number of other studies - precisely 2832 - that are presently open for patient enrollment."

Answered by AI

Has the FDA given approval to Cohort A, which consists of patients who have not received immunotherapy previously?

"According to our team at Power, the safety rating for Cohort A: Immunotherapy Naive is 2 on a scale of 1 to 3. This assessment aligns with it being a Phase 2 trial where there exists some safety data but no efficacy data as yet."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dostarlimab and Cobolimab in Advanced Cervical Cancer

Meghan Shea 2024. "Dostarlimab and Cobolimab in Advanced Cervical Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06238635.

All > Paid Studies Boston > Cervical Cancer